A Center Based Early Intervention Program For Preschoolers With Developmental Disorders

The purpose of this study is to examine the effectiveness of a 12-week early intervention program that will include 12 weekly hours in an intensive center-based preschool environment or in the home to treat social communication deficits in children with developmental disorders. The study will include children with developmental disorders, such as Autism Spectrum Disorder, neurogenetic disorders, or intellectual disability.

Study Overview

• Status: Recruiting
• Conditions: Autism Spectrum Disorder; Developmental Disability; Development Delay; Development Disorder, Child
• Intervention / Treatment: Behavioral: Center Based or In Home Early Intervention Program

• Study Type: Interventional
• Enrollment (Estimated): 75
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Robin Libove, BS; Phone Number: (650) 736-1235; Email: rlibove@stanford.edu
• Study Contact Backup: Name: Madeleine Clark, BS; Phone Number: (650) 736-1235; Email: mclark11@stanford.edu

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Recruiting
      • Stanford University School of Medicine
      • Contact: Madeleine Clark, BS; Phone Number: 650-736-1235; Email: mclark11@stanford.edu
      • Contact: Robin Libove, BS; Phone Number: (650) 736-1235; Email: rlibove@stanford.edu
      • Principal Investigator: Antonio Hardan, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 5 years (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Diagnosis of Developmental Disorder, such as Autism Spectrum Disorder, neurogenetic disorder, or intellectual disability, based on clinical interview;
• Boys and girls between 2.0 years and 5.11 years at time of enrollment;
• Ability to participate in the testing procedures to the extent that valid standard scores can be obtained.

Exclusion Criteria:

• Current or lifetime diagnosis of severe psychiatric disorder (e.g., bipolar disorder, etc.);
• Lack of availability during program hours.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Center Based or In-Home Early Intervention Program	Behavioral: Center Based or In Home Early Intervention Program; This is a 12-week early intervention program that will include 12 weekly hours of treatment in an intensive center-based preschool environment or in home to treat social communication deficits in children with developmental disorders.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Parent Rated Social Responsiveness Scale, 2nd Edition (SRS-2) T-Score After Treatment.	Social Responsiveness Scale, 2nd Edition (SRS) scores measure social abilities with lower scores meaning better social abilities. (T-Score Range: 37- above 90 )	Baseline, 12 Weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Parent Rated Repetitive Behavior Scale Revised (RBS-R) Scores During Treatment.	Higher scores on the Repetitive Behavior Scale- Revised mean higher levels of repetitive and restricted behaviors. (Raw Score Total Range: 0 - 129)	Baseline, 12 Weeks
Change From Baseline in Parent Rated Stanford Social Dimension Scale (SSDS) Scores During Treatment.	Higher Scores on the Stanford Social Dimension Scale mean better social functioning and lower scores mean worse social functioning (Range: 58-290).	Baseline, 12 Weeks
Change From Baseline in Parent Rated Vineland Adaptive Behavior Scale- 3 (VABS-3) Scores During Treatment.		Baseline, 12 Weeks
Change From Baseline in Parent Rated Short Sensory Profile Questionnaire (SSPQ) Scores During Treatment.		Baseline, 12 Weeks
Change From Baseline in Parent Rated General Self Efficacy Scale (GSES) Scores During Treatment.		Baseline, 12 Weeks

Collaborators and Investigators

• Sponsor: Stanford University
• Collaborators: John & Marcia Goldman Foundation
• Investigators: Principal Investigator: Antonio Hardan, MD, Stanford University

Study record dates

Study Major Dates

• Study Start (Actual): October 19, 2019
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: July 17, 2019
• First Submitted That Met QC Criteria: July 17, 2019
• First Posted (Actual): July 19, 2019

Study Record Updates

• Last Update Posted (Estimated): December 14, 2023
• Last Update Submitted That Met QC Criteria: December 13, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Autism Spectrum Disorder; Developmental Disabilities
• Other Study ID Numbers: IRB-52348

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No